NDC 63824-504 Mucinex Nightshift Severe Cold And Flu

Acetaminophen,Dextromethorphan Hydrobromide,Phenylephrine Hydrochloride,And Triprolidine - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
63824-504
Proprietary Name:
Mucinex Nightshift Severe Cold And Flu
Non-Proprietary Name: [1]
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Triprolidine Hydrochloride
Substance Name: [2]
Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride; Triprolidine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Rb Health (us) Llc
    Labeler Code:
    63824
    FDA Application Number: [6]
    part341
    Marketing Category: [8]
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date: [9]
    06-01-2020
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 63824-504-66

    Package Description: 180 mL in 1 BOTTLE

    Price per Unit: $0.05845 per ML

    Product Details

    What is NDC 63824-504?

    The NDC code 63824-504 is assigned by the FDA to the product Mucinex Nightshift Severe Cold And Flu which is a human over the counter drug product labeled by Rb Health (us) Llc. The generic name of Mucinex Nightshift Severe Cold And Flu is acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride. The product's dosage form is solution and is administered via oral form. The product is distributed in a single package with assigned NDC code 63824-504-66 180 ml in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Mucinex Nightshift Severe Cold And Flu?

    This product is used as Active ingredients (in each 20 mL)MUCINEX FAST-MAX COLD & FLUPurposesAcetaminophen 650 mgPain reliever/fever reducerDextromethorphan HBr 20 mgCough suppressantGuaifenesin 400 mgExpectorantPhenylephrine HCl 10 mgNasal decongestantActive ingredients (in each 20 mL) MUCINEX NIGHTSHIFT SEVERE COLD & FLUPurposesAcetaminophen 650 mgPain reliever/fever reducerDextromethorphan HBr 20 mgCough suppressantPhenylephrine HCl 10 mgNasal decongestantTriprolidine HCl 2.5 mgAntihistamine

    What are Mucinex Nightshift Severe Cold And Flu Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • ACETAMINOPHEN 650 mg/20mL - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
    • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
    • PHENYLEPHRINE HYDROCHLORIDE 10 mg/20mL - An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.
    • TRIPROLIDINE HYDROCHLORIDE 2.5 mg/20mL - Histamine H1 antagonist used in allergic rhinitis; ASTHMA; and URTICARIA. It is a component of COUGH and COLD medicines. It may cause drowsiness.

    Which are Mucinex Nightshift Severe Cold And Flu UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Mucinex Nightshift Severe Cold And Flu Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    Which are the Pharmacologic Classes for Mucinex Nightshift Severe Cold And Flu?

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".